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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005852-33 | |||
| 2011-005858-33 | Other Identifier | Eudra CT |
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| Name | Class |
|---|---|
| Medicines for Malaria Venture | OTHER |
The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with uncomplicated falciparum malaria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age >28 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artemether-lumefantrine (COA566) | Drug | One dispersible tablet taken orally twice a day during 3 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate | Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42 | Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 14 and day 42, corrected for re-infection by Polymerase Chain Reaction (PCR) assay. | Day 14 and 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Cotonou | 01 BP 107 | Benin | |||
| Novartis investigative site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25886021 | Derived | Tiono AB, Tinto H, Alao MJ, Meremikwu M, Tshefu A, Ogutu B, Ouedraogo A, Lingani M, Cousin M, Lefevre G, Jain JP, Duparc S, Hamed K. Increased systemic exposures of artemether and dihydroartemisinin in infants under 5 kg with uncomplicated Plasmodium falciparum malaria treated with artemether-lumefantrine (Coartem(R)). Malar J. 2015 Apr 15;14:157. doi: 10.1186/s12936-015-0682-7. |
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The participant that did not complete in the "6 week follow-up phase" was also included in "Follow-up at 12 Months of Age" and was lost to follow-up
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age >28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 6 Week Follow-up Phase |
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| Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42 |
Number of patients with clearance of asexual parasites at day 3, 7, 14, 28 and 42 after initiating study treatment. |
| Day 3, 7, 14, 28 and 42 |
| Percent Change of Parasite Count From Baseline at 24 Hours | Percent change of parasite count from baseline at 24 hours | baseline, 24 hours |
| Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline | Number of participants with parasite density at 48 hours after treatment initiation greater than parasite density at baseline. | 48 hours |
| Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline | Number of participants with parasite density at 72 hours after treatment initiation greater than or equal to 25 percent of parasite density at baseline. | 72 hours |
| Time to Parasite Clearance (PCT) | Time from first dose until first total and continued disappearance of asexual parasite forms which remains at least a further 48 hours. | Up to 7 days |
| Time to Fever Clearance (FCT) | Time from first dose to the first time the axillary body temperature decreased below and remained below 37.5° C for at least 48 hours. | Up to 7 days |
| Time to Gametocyte Clearance (GCT) | Time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours. | Up to 7 days |
| Cotonou |
| Benin |
| Novartis Investigative Site | Burkina Faso | 2208 | Burkina Faso |
| Novartis investigative site | Ouagadougou | Burkina Faso |
| Novartis investigative site | Calabar | Nigeria |
| Novartis investigative site | Kinshasa | Republic of the Congo |
| Novartis investigative site | Lomé | Togo |
| COMPLETED |
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| NOT COMPLETED |
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| Follow-up at 12 Months of Age |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age >28 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | days |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Polymerase Chain Reaction (PCR) Corrected 28 Day Parasitological Cure Rate | Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 28, corrected for re-infection by Polymerase Chain Reaction (PCR) assay. | Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline. | Posted | Number | number of participants | 28 days |
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| Secondary | Polymerase Chain Reaction (PCR) Corrected Parasitological Cure Rate at Day 14 and 42 | Number of participants with clearance of asexual parasites by day 7 after initiating study treatment without recrudescence at day 14 and day 42, corrected for re-infection by Polymerase Chain Reaction (PCR) assay. | Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline. | Posted | Number | Number of participants | Day 14 and 42 |
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| Secondary | Number of Participants With Parasitological Uncorrected Cure Rate at Day 3, 7, 14, 28 and 42 | Number of patients with clearance of asexual parasites at day 3, 7, 14, 28 and 42 after initiating study treatment. | Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline. | Posted | Number | participants | Day 3, 7, 14, 28 and 42 |
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| Secondary | Percent Change of Parasite Count From Baseline at 24 Hours | Percent change of parasite count from baseline at 24 hours | Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline. | Posted | Mean | Standard Deviation | Percent Change | baseline, 24 hours |
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| Secondary | Number of Participants With Parasitaemia at 48 Hours After Treatment Initiation Greater Than at Baseline | Number of participants with parasite density at 48 hours after treatment initiation greater than parasite density at baseline. | Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline. | Posted | Number | participants | 48 hours |
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| Secondary | Number of Participants With Parasitaemia at 72 Hours After Treatment Initiation Greater Than or Equal to 25 Percent of Count at Baseline | Number of participants with parasite density at 72 hours after treatment initiation greater than or equal to 25 percent of parasite density at baseline. | Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline. | Posted | Number | participants | 72 hours |
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| Secondary | Time to Parasite Clearance (PCT) | Time from first dose until first total and continued disappearance of asexual parasite forms which remains at least a further 48 hours. | Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline. | Posted | Mean | Standard Deviation | hours | Up to 7 days |
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| Secondary | Time to Fever Clearance (FCT) | Time from first dose to the first time the axillary body temperature decreased below and remained below 37.5° C for at least 48 hours. | Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline. | Posted | Mean | Standard Deviation | hours | Up to 7 days |
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| Secondary | Time to Gametocyte Clearance (GCT) | Time from first dose until first total and continued disappearance of gametocytes which remains at least a further 48 hours. | Full analysis set (FAS) - all subjects receiving at least one dose of study drug and who are confirmed to have P. falciparum malaria at baseline. | Posted | Mean | Standard Deviation | hours | Up to 7 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days. Infants age >28 days. | 3 | 20 | 16 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Cerebral malaria | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Meningitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Malaria | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Rash pustular | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D008288 | Malaria |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
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| ID | Term |
|---|---|
| D000077611 | Artemether, Lumefantrine Drug Combination |
| ID | Term |
|---|---|
| D000077549 | Artemether |
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
| D009930 | Organic Chemicals |
| D000078102 | Lumefantrine |
| D005449 | Fluorenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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